001118v4.0 - US EN
Sirius Medical Systems
Sirius Pintuition Detector
Instructions for Use
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7.2
E
LECTROMAGNETIC
C
OMPATIBILITY
With the increased number of electronic devices such as PC’s and mobile (cellular)
telephones, medical devices in use may be susceptible to electromagnetic interference from
other devices. Electromagnetic interference may result in incorrect operation of the medical
device and create a potentially unsafe situation. Medical devices should also not interfere
with other devices. In order to regulate the requirements for EMC (Electro Magnetic
Compatibility) with the aim to prevent unsafe product situations, the IEC60601-1-2 standard
has been implemented. This standard defines the levels of immunity to electromagnetic
interferences as well as maximum levels of electromagnetic emissions for medical devices.
Electrical medical devices manufactured by Sirius Medical Systems conform to this
IEC60601-1-2:2014 standard for both immunity and emissions.
Nevertheless, the following needs to be observed:
Warning.
The use of accessories, transducers, sensors, and cables other than
those specified may result in increased electromagnetic emission and/or
decreased electromagnetic immunity of the equipment and/or Pintuition
Detector.
Warning.
The Pintuition Detector should not be used adjacent to or stacked with
other equipment; if adjacent or stacked use is necessary, the Pintuition Detector
shall be observed to verify normal operation in the configuration in which it will
be used.
Caution.
The emissions characteristics of this equipment make it suitable for use
in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment
might not offer adequate protection to radio-frequency communication services.
The user might need to take mitigation measures, such as relocating or re-
orienting the equipment.
Caution.
In
the
unlikely event that the Pintuition Detector is locked inoperable
during use due to electromagnetic disturbances from other devices, disconnect
and reconnect the Pintuition Probe. Make sure the distance to the other device
including any cables is enlarged.
Guidance and m
anufacturer’s declaration –
electromagnetic emissions
Pintuition detector is intended for use in the electromagnetic environment specified below. The user of the device
should assure that it is used in such an environment to prevent improper operation.
Emissions
Compliance
Electromagnetic environment
–
guidance
RF emissions CISPR 11
Group 1
Pintuition detector does not use RF energy for its
intended function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby
electronic equipment.
RF emissions CISPR 11
Class A
The Pintuition detector is suitable for use in all
establishments other than domestic and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Not applicable
